Drugs@FDA: FDA-Approved Drugs
Company: SERONO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERGONAL | MENOTROPINS (FSH;LH) | 75 IU/AMP;75 IU/AMP | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PERGONAL | MENOTROPINS (FSH;LH) | 150 IU/AMP;150 IU/AMP | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/22/1975 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2001 | SUPPL-51 | Supplement |
Label is not available on this site. |
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| 07/30/2002 | SUPPL-49 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17646s049ltr.pdf |
| 08/31/2000 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 10/12/2000 | SUPPL-47 | Supplement |
Label is not available on this site. |
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| 05/20/1999 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
| 02/17/1998 | SUPPL-44 | Supplement |
Label is not available on this site. |
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| 02/18/1998 | SUPPL-43 | Supplement |
Label is not available on this site. |
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| 08/22/1996 | SUPPL-42 | Supplement |
Label is not available on this site. |
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| 01/22/1996 | SUPPL-40 | Supplement |
Label is not available on this site. |
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| 04/05/1995 | SUPPL-39 | Supplement |
Label is not available on this site. |
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| 10/31/1994 | SUPPL-38 | Supplement |
Label is not available on this site. |
||
| 12/06/1993 | SUPPL-37 | Supplement |
Label is not available on this site. |
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| 10/21/1994 | SUPPL-36 | Supplement |
Label is not available on this site. |
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| 06/09/1993 | SUPPL-33 | Supplement |
Label is not available on this site. |
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| 05/31/1994 | SUPPL-32 | Supplement |
Label is not available on this site. |
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| 01/17/1991 | SUPPL-31 | Supplement |
Label is not available on this site. |
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| 02/28/1990 | SUPPL-29 | Supplement |
Label is not available on this site. |
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| 04/18/1988 | SUPPL-28 | Supplement |
Label is not available on this site. |
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| 12/04/1987 | SUPPL-27 | Supplement |
Label is not available on this site. |
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| 03/18/1986 | SUPPL-26 | Supplement |
Label is not available on this site. |
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| 08/23/1985 | SUPPL-25 | Supplement |
Label is not available on this site. |
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| 05/20/1985 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 07/29/1985 | SUPPL-23 | Supplement |
Label is not available on this site. |
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| 05/20/1985 | SUPPL-22 | Supplement |
Label is not available on this site. |
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| 08/23/1989 | SUPPL-21 | Supplement |
Label is not available on this site. |
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| 09/15/1986 | SUPPL-20 | Supplement |
Label is not available on this site. |
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| 07/18/1983 | SUPPL-18 | Supplement |
Label is not available on this site. |
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| 07/11/1983 | SUPPL-16 | Supplement |
Label is not available on this site. |
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| 07/18/1983 | SUPPL-14 | Supplement |
Label is not available on this site. |
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| 02/11/1982 | SUPPL-13 | Supplement |
Label is not available on this site. |
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| 10/22/1981 | SUPPL-11 | Supplement |
Label is not available on this site. |
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| 10/28/1980 | SUPPL-10 | Supplement |
Label is not available on this site. |
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| 10/26/1979 | SUPPL-5 | Supplement |
Label is not available on this site. |
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| 01/20/1982 | SUPPL-1 | Supplement |
Label is not available on this site. |